Regulatory Pathway and Safety Assessment of Graphene-based products

SAFEGRAPH is a “Health and Safety Spearhead Project” that complements the technological Spearhead Projects (SHPs), which is in turn a subproject of the “Graphene Flagship” by the European Commission. The goal of SAFEGRAPH will be a regulatory strategy (white paper) and market authorization pathway, which, coupled to an occupational, consumer and environmental risk assessment, will support the projects to reach the market, paving the way for the future. One main aim of this project is to cover regulatory safety assessment at different stages of the innovation process, hence the selection of Core2 and Core3 SHP projects, which will allow providing regulatory strategies covering from research prototype to close to market launch. Different TRLs are important to develop and test best practices along the product development process (from prototypes to product tested in relevant environments). This strategy will guarantee the highest impact possible regarding SAFEGRAPH outputs. Different approaches will be used to assess safety at different TRLs, from screening tools to complex and quantitative testing methods. The BOKU will mainly be responsible to develop strategies regarding recycling and safe disposal of nano-enabled products. The resulting approach intends to be used in future graphene projects from early stages to assure faster to market times and sustainable (safe-by-design) products. From a regulatory viewpoint, the selected SHPs cover a wide range of sectors, with different levels of nano-safety regulatory development, which will support the development of a regulatory strategy as wide as possible. This project will address the main regulatory needs in the current market represented by medical devices, food -drinking water-, aerospace, and wearables. All selected projects have potentially high impact on quality of life of users, to increase environmental sustainability, and to improve health monitoring and protection. Itis thus one main aim of this project to support these future products to reach the market in a cost/safe efficient and timely manner.